Senior Quality Control Manager

2 weeks ago


Hazelwood, Missouri, United States BioFire Diagnostics Full time
Job Summary:

As a Senior Quality Control Manager at BioFire Diagnostics, you will be responsible for leading the Reagents Incoming Quality Control department to ensure compliance with all regulations, quality systems, and customer requirements. Your expertise in quality control processes, personnel, and testing methods will be essential in maintaining the highest standards of quality.

Key Responsibilities:

  • Develop and maintain quality performance metrics to assess the effectiveness of production processes, current specifications, test methods, and personnel performance.
  • Manage incoming inspections, in-process inspections, and analytical/physical testing of materials to ensure the quality of Incoming/In-Process materials.
  • Develop and implement inspection, physical/analytical testing, and operational procedures to ensure continuous product and process improvement.
  • Lead efforts to ensure the quality of Incoming/In-Process materials to maximize the utilization of resources to meet budgetary goals.
  • Develop and maintain regular Quality Control trend data and provide periodic reports to management.

Requirements:

  • A 4-year degree in a scientific or technical field with three (3) years progressively responsible experience in a relevant industry (such as medical device) with advanced knowledge of QC chemicals/materials, testing, and inspection procedures.
  • High School Diploma/GED with eight (8) years progressively responsible experience in a relevant industry (such as medical device) with advanced knowledge of QC chemicals/materials, testing, and inspection procedures also accepted.
  • A minimum of one (1) year experience supervisory experience is highly preferred.
  • Proven excellent verbal and written communication skills are a must as this position interacts at all levels of the organization.
  • Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.).
  • Must have a strong knowledge of GMP, ISO, and FDA compliance.


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